Estimation of toxic hazard—A decision tree approach

Cramer, G.M.; Ford, R.A.; Hall, Richard

doi:10.1016/s0015-6264(76)80522-6

Cited by 1,348 publications

(725 citation statements)

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“…A factor of three was used to adjust the NOEL from studies of shorter than chronic duration and designated with an asterisk in the original publication (note that whilst the adjusted values were used in the derivation of the TTC values, they were not explicitly cited in the published tables but indicated with asterisks). The dataset of 613 substances was also divided into the three structural classes defined by Cramer et al (1978); 137 substances to Class I, 28 to Class II, and 448 to Class III. The three Cramer Classes became the basis of grouping chemicals in the current TTC paradigm.…”

Section: Munro Ttc Datasetmentioning

confidence: 99%

“…Metal ions (Naþ, Ca2þ, or Fe3þ, etc.) were not removed from the connection table due to the nature of the questions in the decision tree (Cramer et al, 1978). The comparison of assignments for 609 unique structures between Munro and Toxtree v2.6.13 are summarized in Table 3.…”

Section: Cramer Classifications By Toxtree and Munromentioning

confidence: 99%

“…There has been considerable discussion of the Cramer classification system, which was first proposed by Cramer et al (1978). It has been deemed still fit for purpose by European advisory bodies (EFSA, 2012;SCCS, SCHER and SCENIHR, 2012).…”

Section: The Effect Of Cramer Classificationsmentioning

confidence: 99%

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Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

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a b s t r a c tA new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-AdverseEffect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 mg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 mg/kg-bw/day are broadly similar to those of the original Munro dataset.

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Section: Munro Ttc Datasetmentioning

confidence: 99%

Section: Cramer Classifications By Toxtree and Munromentioning

confidence: 99%

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Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Yang

Barlow²,

Jacobs

et al. 2017

Food and Chemical Toxicology

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“…Based upon the conclusion on genotoxicity of the structurally related substances in FGE.10Rev1, the Panel concluded that the data available do not preclude an evaluation of the six flavouring substances evaluated by the JECFA in the group of aliphatic acyclic diols, triols, and related substances through the Procedure. According to JECFA three of the substances belong to structural class I and three to structural class III using the decision tree approach presented by Cramer et al (Cramer et al, 1978).…”

Section: Efsa Considerationsmentioning

confidence: 99%

“…The evaluations of the six aliphatic acyclic diols, triols, and related substances are summarised in Fifty-one of the candidate substances are classified into structural class I, six are classified into structural class II, and one into structural class III, according to the decision tree approach by Cramer et al (Cramer et al, 1978).…”

Section: Efsa Considerationsmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 92 (FGE.92): Consideration of aliphatic acyclic diols, triols, and related substances evaluated by JECFA (68th meeting) structurally related to aliphatic primary and secondary saturated and unsaturated alc

Flavourings¹

2010

EFSA Journal

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Suggested citation: EFSA ; Scientific Opinion on Flavouring Group Evaluation 92 (FGE.92): Consideration of aliphatic acyclic diols, triols, and related substances evaluated by JECFA (68th meeting) structurally related to aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones evaluated by EFSA in FGE.10Rev1 (2009 The Panel concluded that the six substances in the JECFA flavouring group are structurally related to the group of aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones evaluated by the European Food Safety Authority (EFSA) in the Flavouring Group Evaluation 10, Revision 1 (FGE.10Rev1).The Panel agrees with the application of the Procedure as performed by the JECFA for all six substances. So, for the six named compounds there is no safety concern at the estimated level of intake as flavouring substance based on the MSDI approach.For five substances, use levels have been provided by the Industry 06.087, 06.089, 09.632 and 09.919]. The mTAMDI figures calculated for the five substances are above the threshold of concern for their structural classes. For these substances more reliable data are needed. On the basis on such data the flavouring substances should be reconsidered using the Procedure. For the remaining substance .090] use levels are needed to calculate the mTAMDI in order to identify if more refined exposure assessment is needed to finalise the evaluation.In order to determine whether the conclusion for the six JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications are available for one of the six materials of commerce. For the remaining five substances For the remaining substance .090] the Panel agrees with the JECFA conclusion "No safety concern at estimated level of intake as flavouring substance" based on the MSDI approach.

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Toxicology of Flavoring Ingredients in the Food Industry

Pecquet,

Bates,

Maier

2023

Patty's Toxicology

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The present chapter represents toxicological information on selected flavoring ingredients commonly found in the food and beverage product manufacturing workplace. Many flavoring ingredients are considered Generally Recognized as Safe (GRAS) based on consumer oral ingestion but can present hazards in the occupational context depending on route of exposure and exposure concentration. Therefore, when occupational exposure limits do not exist, it is important that workers review safety data sheets (SDS) and other hazard information and participate in training to understand the verbiage on these resources as part of a comprehensive hazard communication program. New occupational hazard assessment approaches include hazard banding when data are scarce and use of the threshold of toxicological concern (TTC) to inform risk management planning in the food and beverage sectors. The Flavor Extract Manufacturers Association (FEMA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) have adopted modified Cramer approaches and the TTC concept to classify flavor ingredients by structure for dietary exposure and safety assessment considerations when chemical‐specific data are limited. Today, new chemical entities are being designed and created to maximize and/or customize the interaction of the flavor ingredients with taste receptors, including new applications of flavoring compounds to use in Electronic Nicotine Devices (ENDs) that involve inhalation route exposures. Several important flavor chemicals have been covered in this chapter with respect to their properties, exposure assessment, toxicity, and regulations pertaining to risk and safety assessments for different use scenarios.

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Estimation of toxic hazard—A decision tree approach

Cited by 1,348 publications

References 1 publication

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Thresholds of Toxicological Concern for cosmetics-related substances: New database, thresholds, and enrichment of chemical space

Scientific Opinion on Flavouring Group Evaluation 92 (FGE.92): Consideration of aliphatic acyclic diols, triols, and related substances evaluated by JECFA (68th meeting) structurally related to aliphatic primary and secondary saturated and unsaturated alc

Toxicology of Flavoring Ingredients in the Food Industry

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